NCT06812156

Brief Summary

Interventions that can improve cardiovascular health behaviors in children are of critical importance for reducing the burden of cardiovascular disease in the future. The research will be conducted to evaluate the effectiveness of nursing interventions aimed at improving heart health in children. The study employs a pre-test post-test control group experimental design. The sample of the study consists of a total of 100 students, with 50 in the experimental group and 50 in the control group. The research will be conducted with students from two middle schools selected through simple random sampling method from Mamak district, Ankara province. Socio-demographic Data Collection Form and Cardiovascular Health Behavior Scale for Children will be used during the data collection process. A 5-week educational plan aimed at improving cardiovascular health behaviors will be implemented for the experimental group, while no intervention will be made for the control group. Research data will be analyzed using Statistical Package for Social Sciences (SPSS) 25.0 program. Continuous variables will be reported using mean (x̅) and standard deviation (SD), while number (n) and percentage (%) will be used for categorical variables. All tests will consider statistical significance at the level of p \< 0.05. For the study to be conducted, ethical approval will be obtained from the Ankara University Rectorate Ethics Committee, institutional permission will be obtained from the Ankara Provincial Directorate of National Education, and verbal consent from the included students and written consent from their parents will be obtained.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

February 1, 2025

Last Update Submit

May 12, 2025

Conditions

Keywords

ChildCardiovascular DiseasesHealth BehaviorSchool HealthNursing InterventionVirtual Reality

Outcome Measures

Primary Outcomes (2)

  • Sociodemographic Data Collection Form

    This form includes questions about the student's age, gender, height, weight, parental education level, family income level, the presence of a family member or close relative who has had a heart attack, and the presence of a family member or close relative using blood pressure medication.

    5 weeks

  • Cardiovascular Health Behavior Scale for Children

    The Cardiovascular Health Behavior Scale for Children was developed by Çelik and Bektaş to evaluate behaviors affecting children's cardiovascular health in a current and accurate manner (Çelik \& Bektaş, 2020). The scale consists of subdimensions including nutrition, exercise, sedentary lifestyle, smoking, self-love, and stress. It measures cardiovascular health behavior levels with items such as "I eat chocolate, candy, or biscuits when I feel hungry, even if it's not mealtime," "I prefer to spend my free time doing sports," "I watch TV for more than 2 hours a day," "I feel uncomfortable when someone smokes near me," "I like my appearance," and "I worry about my schoolwork." The scale includes a total of 28 items scored on a 4-point Likert scale ranging from 1 (Always) to 4 (Never). While scoring, 15 items (1, 2, 3, 4, 5, 6, 7, 13, 14, 15, 16, 25, 26, 27, 28) are reverse-coded. Scores on the scale range from 28 to 112, with higher scores indicating a higher level of negative behavio

    5 weeks

Secondary Outcomes (1)

  • Cardiovascular Health Behavior Scale for Children

    5 weeks

Study Arms (2)

experimental group

OTHER

A group of 43 sixth-grade students in the experimental group received five sessions of education on cardiovascular health, followed by a virtual reality video viewing session using VR goggles.

control group

NO INTERVENTION

The 47 students in the control group did not receive any intervention; only measurements were conducted.

Interventions

This intervention aims to promote healthy behavioral changes at both individual and community levels by supporting education with virtual reality technology.

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Actively attending school where the research is conducted, Being a 6th-grade student, Willing to voluntarily participate in the research, Having written parental consent to participate in the research.

You may not qualify if:

  • Interrupting the active education process during the research due to health problems or similar reasons, Changing schools, Having a chronic illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mehmet Çekiç Middle School

Ankara, Ankara, 06620, Turkey (Türkiye)

Location

Sibel-İsmet Çatık Middle School

Ankara, Ankara, 06620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cardiovascular DiseasesHealth Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The intervention study model involves a controlled and intervention-based approach to evaluate the impact of a variable in a specific population. In the study, educational and awareness-raising activities, as well as augmented reality technologies, were implemented in the intervention groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
nurse

Study Record Dates

First Submitted

February 1, 2025

First Posted

February 6, 2025

Study Start

November 10, 2024

Primary Completion

December 17, 2024

Study Completion

January 10, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations